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NCT04634500 Clinical Trial

The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.

T2DM (Type 2 Diabetes Mellitus) Clinical Trial

— ENHANCE-M  

Official title:
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04634500
Other study ID # DW_DWP16001302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 18, 2020
Est. completion date November 3, 2021

Study information
Verified date October 2022
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

Description:

A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date November 3, 2021
Est. primary completion date November 3, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility Inclusion Criteria: 1. Subjects with T2DM aged 19 to 80 years 2. Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% = HbA1c = 10.5% 3. Subjects with BMI of 20-45 kg/m2 4. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study Exclusion Criteria: 1. Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors) 2. Diabetic ketoacidosis, diabetic coma or precoma within the past year 3. Urinary tract infections or genital infections within 4. Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg) 5. eGFR < 60 mL/min/1.73 m2 6. Severe heart failure (NYHA class III/IV)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dapagliflozin
Dapagliflozin Tablet

Locations
Country Name City State
Korea, Republic of Daewoong pharmatceutical Soeul

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in HbA1c at 24 weeks
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